TPLC - Total Product Life Cycle

• Device: orthopedic stereotaxic instrument
• Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
• Product Code: OLO
• Regulation Number: 882.4560
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
7D SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
7D SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	9
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	5
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	11
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	6
CORIN LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CUREXO, INC.
	SUBSTANTIALLY EQUIVALENT	3
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	2
ECENTIAL ROBOTICS
	SUBSTANTIALLY EQUIVALENT	2
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FIAGON GMBH
	SUBSTANTIALLY EQUIVALENT	1
FUSION ROBOTICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU LANCET ROBOTICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	2
KALITEC DIRECT, LLC DOING BUSINESS AS KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
KICO KNEE INNOVATION COMPANY PTY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	4
MAZOR ROBOTICS LTD.
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTECH S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC SOFAMOR DANEK, USA INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NAVIBOT INTERNATIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NAVBIT PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	2
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
ONPOINT SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOKEY ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	5
ORTHOSOFT INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	3
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PATHKEEPER SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
POINT ROBOTICS MEDTECH INC.
	SUBSTANTIALLY EQUIVALENT	2
POLARISAR INC.
	SUBSTANTIALLY EQUIVALENT	1
PRACTICAL NAVIGATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
PREMIA SPINE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROPRIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
REMEX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	1
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL THEATER, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	7
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	1
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	1585	1585
2020	2744	2744
2021	1696	1696
2022	1568	1576
2023	1491	1491
2024	710	710

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1026	1026
Material Integrity Problem	840	840
Mechanical Problem	718	718
Use of Device Problem	630	630
Device Slipped	489	489
Fracture	444	444
Unintended Application Program Shut Down	441	441
Application Program Problem: Parameter Calculation Error	416	416
Incorrect, Inadequate or Imprecise Result or Readings	349	349
Connection Problem	347	347
Computer Software Problem	319	319
Imprecision	316	316
Detachment of Device or Device Component	286	286
Insufficient Information	265	265
Non Reproducible Results	235	235
Adverse Event Without Identified Device or Use Problem	234	234
Physical Resistance/Sticking	206	206
Unintended Movement	199	199
Mechanical Jam	185	185
Material Twisted/Bent	184	184
Device-Device Incompatibility	161	161
Application Program Problem	152	152
Residue After Decontamination	148	148
Output Problem	144	144
Malposition of Device	135	135
Defective Component	126	126
Positioning Problem	117	117
Human-Device Interface Problem	112	112
Display or Visual Feedback Problem	112	112
Solder Joint Fracture	110	110
Failure to Calibrate	102	102
Overheating of Device	95	95
Mechanics Altered	94	94
Positioning Failure	88	88
Intermittent Continuity	87	87
Material Fragmentation	76	76
Intermittent Communication Failure	68	68
Appropriate Term/Code Not Available	67	67
Loose or Intermittent Connection	66	66
Improper or Incorrect Procedure or Method	63	63
Noise, Audible	63	63
Premature Separation	62	62
Application Program Freezes, Becomes Nonfunctional	62	62
Failure to Recalibrate	62	62
Device Sensing Problem	61	61
Circuit Failure	58	58
Material Frayed	57	57
Material Deformation	57	57
Complete Loss of Power	47	47
Difficult to Insert	44	44
Incorrect Measurement	44	44
Image Display Error/Artifact	43	43
No Apparent Adverse Event	42	42
Computer Operating System Problem	40	40
Contamination /Decontamination Problem	36	36
Intermittent Loss of Power	35	35
Leak/Splash	34	34
Unstable	33	33
Retraction Problem	32	32
Inappropriate Tactile Prompt/Feedback	32	32
Defective Device	31	31
Entrapment of Device	30	30
Crack	30	30
Failure to Power Up	29	29
No Visual Prompts/Feedback	29	29
Calibration Problem	25	25
Contamination of Device Ingredient or Reagent	25	25
Deformation Due to Compressive Stress	24	24
Vibration	24	24
Difficult to Remove	24	24
Electrical /Electronic Property Problem	24	24
Difficult or Delayed Positioning	22	22
Suction Problem	22	22
No Display/Image	21	21
Material Split, Cut or Torn	21	21
Naturally Worn	19	19
Device Dislodged or Dislocated	19	19
Erratic or Intermittent Display	18	18
Inadequacy of Device Shape and/or Size	18	18
Unintended System Motion	18	18
Communication or Transmission Problem	17	17
Component Missing	17	17
Battery Problem	16	16
Electrical Shorting	16	16
Nonstandard Device	16	16
Sharp Edges	16	16
Fluid/Blood Leak	15	15
Electrical Power Problem	14	14
Separation Failure	14	14
Operating System Becomes Nonfunctional	14	14
Power Problem	14	14
Loss of Osseointegration	13	13
Fitting Problem	13	13
Image Orientation Incorrect	13	13
Degraded	12	12
Off-Label Use	11	11
Separation Problem	11	11
Interrogation Problem	10	10
Corroded	10	10
Failure to Cut	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5274	5282
No Known Impact Or Consequence To Patient	2068	2068
No Patient Involvement	901	901
No Consequences Or Impact To Patient	634	634
Injury	300	300
Unspecified Tissue Injury	188	188
Foreign Body In Patient	137	137
Insufficient Information	131	131
Spinal Column Injury	111	111
Pain	106	106
Bone Fracture(s)	70	70
Unspecified Infection	51	51
No Code Available	40	40
Device Embedded In Tissue or Plaque	38	38
Laceration(s)	37	37
Tissue Damage	36	36
Nerve Damage	28	28
No Information	28	28
Failure of Implant	27	27
Joint Laxity	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	24	24
Unspecified Nervous System Problem	23	23
Muscle Weakness	22	22
Cerebrospinal Fluid Leakage	20	20
Inadequate Osseointegration	17	17
Discomfort	16	16
Hemorrhage/Bleeding	15	15
Loss of Range of Motion	12	12
Ambulation Difficulties	12	12
Post Operative Wound Infection	11	11
Deformity/ Disfigurement	11	11
Hip Fracture	10	10
Numbness	9	9
Fibrosis	8	8
Perforation	7	7
Complaint, Ill-Defined	6	6
Wound Dehiscence	6	6
Spinal Cord Injury	6	6
Iatrogenic Source	5	5
Missing Value Reason	5	5
Erosion	5	5
Fall	5	5
Damage to Ligament(s)	5	5
Hematoma	5	5
Joint Dislocation	5	5
Neuropathy	5	5
Paralysis	5	5
Paresis	5	5
Seroma	4	4
Rupture	4	4
Headache	4	4
Swelling/ Edema	4	4
Not Applicable	3	3
Muscle/Tendon Damage	3	3
Paraplegia	3	3
Tissue Breakdown	3	3
Fluid Discharge	3	3
Inflammation	3	3
Aspiration/Inhalation	3	3
Bacterial Infection	3	3
Scar Tissue	3	3
Urinary Retention	3	3
Swelling	2	2
Osteolysis	2	2
Impaired Healing	2	2
Cardiac Arrest	2	2
Fever	2	2
Cyst(s)	2	2
Osteopenia/ Osteoporosis	2	2
Dizziness	2	2
Vertebral Fracture	2	2
Peripheral Nervous Injury	2	2
Test Result	2	2
Blood Loss	2	2
Nervous System Injury	2	2
Physical Asymmetry	2	2
Injection Site Reaction	1	1
Movement Disorder	1	1
Tactile Disorders	1	1
Embolism/Embolus	1	1
Blister	1	1
Needle Stick/Puncture	1	1
Skin Tears	1	1
Sleep Dysfunction	1	1
Cognitive Changes	1	1
Lethargy	1	1
Bowel Perforation	1	1
Patient Problem/Medical Problem	1	1
Deposits	1	1
Dysphagia/ Odynophagia	1	1
Dyspnea	1	1
Erythema	1	1
Chest Pain	1	1
Cellulitis	1	1
Stroke/CVA	1	1
Bruise/Contusion	1	1
Burn(s)	1	1
Abscess	1	1
Achalasia	1	1
Infiltration into Tissue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alphatec Spine, Inc.	II	Nov-08-2022
2	Blue Belt Technologies, Inc	II	Jan-11-2024
3	Blue Belt Technologies, Inc	II	Oct-05-2023
4	Blue Ortho	II	Oct-23-2020
5	Blue Ortho	II	Feb-11-2020
6	Brainlab AG	II	Mar-28-2023
7	Brainlab AG	II	Aug-29-2020
8	Brainlab AG	II	Aug-13-2020
9	DePuy Orthopaedics, Inc.	II	May-02-2022
10	Exactech, Inc.	II	Jun-30-2023
11	Globus Medical, Inc.	II	Feb-07-2024
12	Globus Medical, Inc.	I	Jan-18-2024
13	Intellijoint Surgical, Inc.	II	Mar-23-2020
14	Intellijoint Surgical, Inc.	II	Aug-08-2019
15	K2M, Inc	II	Oct-07-2019
16	Mako Surgical Corporation	II	Sep-09-2022
17	Mako Surgical Corporation	II	Nov-19-2020
18	Mako Surgical Corporation	II	Jul-31-2020
19	Mako Surgical Corporation	II	Jun-16-2019
20	Mazor Robotics Ltd	II	Oct-12-2023
21	Mazor Robotics Ltd	II	Dec-20-2019
22	Medacta Usa Inc	II	Dec-03-2022
23	Medtronic Navigation, Inc.	II	Jan-10-2024
24	Medtronic Navigation, Inc.	II	Jun-09-2020
25	Medtronic Navigation, Inc.	II	Apr-10-2020
26	Medtronic Navigation, Inc.	II	Dec-19-2019
27	Medtronic Sofamor Danek USA, Inc	II	Aug-09-2023
28	NuVasive Inc	III	Feb-03-2023
29	OMNIlife science Inc.	II	Jun-04-2019
30	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
31	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Nov-02-2020
32	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-31-2020
33	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-27-2020
34	Smith & Nephew, Inc.	II	Apr-01-2020
35	Think Surgical, Inc.	II	Mar-20-2024